References

G. References

• Statutory instrument 2004/1031: The Medicines for Human Use (Clinical Trials) Regulations 2004.

• Statutory Instrument 2006/1928: The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006.

Appendix I
Notification Examples

Notification Examples

Notified by: Issue: Would MHRA have expected this case to be notified?
Sponsor Dosing error. Ethics Committee & MHRA informed. Subjects withdrawn. The sponsor stated that there were no serious consequences to subjects or data. No, if there was no significant impact on the integrity of trial subjects or on scientific validity of the trial.
Sponsor Patient Information Leaflet and Informed Consent updated. At one trial site this was not relayed to the patients until approximately 2-3 months after approval. More information on the potential consequences of the delay should have been provided. Possibly not. If this was not a systematic or persistent problem and if no harm to trial subjects resulted from the delay.

Yes, if there was a significant impact on the integrity of trial subjects.
Sponsor Visit date deviation. A common deviation in clinical trials. No. Minor protocol deviation, which does not meet the criteria for notification.
Contractor Investigator failed to report a single SAE as defined in the protocol (re-training provided). No, if it did not result in this or other trial subjects being put at risk, and if it was not a systematic or persistent problem.

In some circumstances, failure to report a SUSAR could have a significant impact on trial subjects. Sufficient information should be provided for the impact to be assessed.
Identified during inspection prior to the current requirement to report serious breaches Investigator site failed to reduce or stop trial medication, in response to certain laboratory parameters, as required by the protocol. This occurred with several patients over a one year period, despite identification by the monitor of the first two occasions. Patients were put at increased risk of thrombosis. Yes, under the current requirements, this should have been reported as a serious breach.
Sponsor Becomes aware of fraud at investigator site in the UK, which does not affect the overall scientific value of the Sponsor’s trial or the integrity of trial subjects in the UK. However, the Sponsor is aware that the fraudster was involved in trials being sponsored by other organisations. Although, in this situation, not a legal requirement under 29A, MHRA encourages voluntary reporting of all fraud cases in the UK, because MHRA will wish to establish the impact on the other trials in case subject integrity or the scientific value of those trials was compromised.

Appendix II
Notification Form
Notification of Serious Breach of Good Clinical Practice or the Trial Protocol
(Ref: UK Statutory Instrument 2006:1928, Regulation 29A)

Your Name:

Your Organisation:
Your Contact Details:

Date Breach Identified by Sponsor:

Details of Individual or Organisation committing breach:

Details of related study (e.g. study title, EudraCT No) if applicable:

Please give details of the breach. Where possible, please include your rationale (e.g. patient safety / data integrity issue and relevant legislation if known).

(continue on additional sheets if required)

Please give details of action taken:
(continue on additional sheets if required)

______________________________________________________________
FOR MHRA USE ONLY:

Date Received:
GCP Ref Number:

Please forward this notification to GCP-PV.Inspectors@mhra.gsi.gov.uk OR GCP Inspectorate, MHRA, 18-103, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.